What’s New in the Patient Safety World

June 2014

New Epidural Corticosteroid Warning

 

 

Epidural steroids are still widely used for treatment in patients with low back pain despite conflicting evidence on their efficacy and fact that they are not FDA-approved for that indication.

 

While questions about efficacy have always existed, most have had little concern about the safety of epidural steroids. Then in 2012 and 2013 there was the infamous multistate outbreak of fungal meningitis and other infections among patients who received contaminated preservative-free steroid injections from a Massachusetts compounding pharmacy. While infections from those affected any space into which the contaminated steroids were injected, many such cases involved fungal meningitis, epidural abscess, arachnoiditis and other localized spinal or paraspinal infections following epidural steroid injection.

 

Now the FDA has just issued a warning about other potential complications of epidural spinal injections (FDA 2014), unrelated to the above outbreak. The FDA is requiring a warning on the drug labels of injectable corticosteroids to indicate the risk for serious adverse effects including loss of vision, cortical blindness, spinal cord infarction, paraplegia, quadriplegia, stroke, seizures, nerve injury, cerebral edema, and death. The FDA identified such complications from their FDA Adverse Event Reporting System (FAERS) and review of the literature. In many cases the adverse neurological event followed the epidural injection within minutes to 48 hours. They provide an excellent bibliography of 17 articles on complications of epidural steroid injections.

 

The FDA further plans to convene an Advisory Committee meeting of external experts in late 2014 to discuss the benefits and risks of epidural corticosteroid injections and to determine if further FDA actions are needed.

 

 

 

References:

 

 

FDA. FDA requires label changes to warn of rare but serious neurologic problems after epidural corticosteroid injections for pain. FDA Safety Announcement April 23, 2014

http://www.fda.gov/downloads/Drugs/DrugSafety/UCM394286.pdf

 

 

 

 

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